For The Candidates
(2) Ra Director - Regulatory affairs - strategy - biologics
NJ
Type:
Full-Time
Category:
Regulatory Affairs
Job ID:
754
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Opportunity Description:
(908) Area Code Northern New Jersey
Regulatory Director
| Job Summary: |
GENERAL SUMMARY
Directly responsible for the organization and preparation of IND/CTA submissions. Coordinates the activities required to maintain the IND/CTA filings in Regulatory Compliance. Participates in compliance activities including SOP creation/revision and departmental training exercises.
ESSENTIAL DUTIES AND
RESPONSIBILITIES:
1.Direct the preparation (content ) of submissions (INDs, IND amendments, CTAs, CTA amendments, BLAs and BLA supplements and periodic reports) to the Health Agencies. Responsible for coordination with Regulatory CROs for CTA activites if appropriate.
2.Responsible for direct coordination /liaison between Health Agency representatives and function groups within the Co.
3.Provide guidance to multifunctional development teams concerning strategic decisions and health authority interactions.
4.Responsible for liaison activities with functional groups within the co. to ensure timely and accurate reporting of information.
5.Participates in the creation, review and revision of the department policies, work instructions and standard operating procedures.
ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:
1.BS/MS in life science with minimum of 5 years experience in regulatory affairs
2.Must possess a thorough understanding of the drug development/regulatory process with stong experience in biologic oncology development.
3.Experience in GCPs and regulatory compliance preferable.
4.Demonstrate a thorough knowledge of the intent, meaning, interpretation and application of FDA and ICH regulations. Knowledge of foreign regulations, guidelines and practices for conducting clinical investigations is desired.
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| Travel Requirements: |
Up to 10%
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| Employment Type: |
Full-Time
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